Zantac Lawsuit

• October 11, 2023: Wisner Baum and The Moore Law Group have reached Zantac settlement agreements in four more cases scheduled for trial in California state court. The settlements resolve four bellwether lawsuits alleging Zantac causes breast cancer.     
  
  Wisner Baum and The Moore Law Group provided the following statement to the media:     
  
  GlaxoSmithKline (“GSK”), the pharmaceutical company that invented and sold Zantac for decades, has agreed to settle four of the bellwether trials in California state court where the Plaintiffs have asserted claims that their usage of Zantac caused them to develop breast cancer.  The first of the breast cancer bellwether trials was set to begin next month on November 13th in Alameda County, California.  “On behalf of our clients, we are extremely pleased that GSK agreed to resolve the claims of these women,” Jennifer A. Moore and R. Brent Wisner, co-lead of the coordinated state court proceeding in California, and the lawyers for these four women.     
   
• September 1, 2023: The first Zantac trial will be a breast cancer case. The trial is still scheduled for November 13, 2023 in Alameda County, California. While the result of the California trial will not have a binding impact on other Zantac cases pending in other state courts, the case will be closely monitored to see how the jury responds to the plaintiff’s evidence and experts.     
  
  The next Case Management Conference for the consolidated Zantac cases in California will take place on September 19. We anticipate other bellwether trials to be scheduled on that date or soon thereafter.     
  
  This week, attorneys filed a lawsuit in Connecticut alleging plaintiffs were diagnosed with bladder, breast, prostate, and other forms of cancer after taking Zantac and generic ranitidine. There are now six state courts with Zantac cases (California, Connecticut, Delaware, Illinois, Nevada, and Pennsylvania).    
   
• July 18, 2023: Today’s case management conference (CMC) provided a few updates for the Delaware Zantac litigation. Plaintiffs’ expert reports will be submitted on July 31, 2023. The court will hold hearings on Daubert from January 22-25, 2024. Like the Sargon hearings in the California state court litigation, Daubert hearings allow the legal teams for the plaintiffs and the defendants to present expert witnesses and educate the court on the science underpinning their arguments.     
  
  Once Daubert is completed, the judge will determine whether or not the experts used valid methodologies. If the judge finds that the plaintiffs’ experts used valid methodologies to arrive at their conclusions, then Zantac cases in Delaware state court can proceed to trial. Experts will be allowed to provide evidence and testimony on whether Zantac causes cancer, and whether that propensity for inducing cancer caused a particular Zantac user’s cancer.      
   
• July 3, 2023: The first Zantac trial is scheduled for November 13, 2023 in Superior Court of California, Alameda County. R. Brent Wisner of Wisner Baum and Jennifer Moore of the Moore Law Group will serve as co-lead trial counsel. The plaintiff in the first case will be named in the coming weeks. Check back for further details as the litigation continues.    
   
• June 23, 2023: Jennifer A. Moore, founder of Moore Law Group, PLLC, and R. Brent Wisner, managing partner of Wisner Baum, recently negotiated a Zantac settlement of the first case set to go to trial in the California Ranitidine Products Cases JCCP 5150. On behalf of our client, Mr. James Goetz, who took Zantac and developed bladder cancer, we are pleased that Defendant, GlaxoSmithKline, agreed to settle and finally bring closure to Mr. Goetz.    
   
• June 15, 2023 – We are nearly a month away from the first Zantac cancer trial. Our firm’s managing partner and senior trial attorney R. Brent Wisner will co-lead the case of James Goetz v. GlaxoSmithKline, LLC with attorney Jennifer Moore of the Moore Law Group. The trial will take place in the same court where Wisner and colleagues previously won a $2.055 billion jury verdict in the Roundup cancer litigation.    
   
• May 16, 2023 – The judge overseeing consolidated Zantac cases in Delaware State Court issued an order appointing R. Brent Wisner as co-lead counsel for the plaintiffs. Wisner will be joined by Jennifer Moore (Moore Law Group), Raeann Warner (Jacobs & Crumplar), and Justin Parafinczuk (Parafinczuk Wolf) in the plaintiffs’ leadership, which is responsible for presenting the plaintiffs’ position in all pretrial matters, initiating and coordinating pretrial discovery, and more.     
  
  “The formation of a new venue for these cases creates more opportunity for our clients and other people throughout the country stricken with cancer after taking a drug that we believe is dangerous,” says Wisner. “We look forward to presenting evidence at trial that Zantac causes cancer, and that the defendants have known about the risks for decades.”     
  
  As of this writing, more than 77,000 cases are pending in Delaware, with plaintiffs from every U.S. state represented in the ongoing litigation. Important dates for the Delaware litigation can be found on our Zantac Trial Schedule page.

What is NDMA in Zantac?

N-Nitrosodimethylamine (NDMA) is a water-soluble organic (containing the element carbon) chemical and appears as a yellow liquid with little or no obvious taste or odor. NDMA was once used to make rocket fuel, but today is made only for research purposes. It can also be produced as a byproduct of manufacturing processes. Humans can be exposed to NDMA in relatively small amounts through various products, including tobacco, foods (cured meat, fish, cheese, beer), shampoos, cleansers, and pesticides.

NDMA is carcinogenic even in minimal doses. The FDA’s acceptable daily intake of NDMA is 96 nanograms (ng), or 96 billionths of a gram. Studies show that NDMA exposure as little as 179 ng per 100 grams per day is associated with elevated cancer risks.

The International Agency for Cancer Research (IARC), the most recognized cancer research institution in the world, studied over 200 research papers on NDMA and the NDMA cancer risk. IARC placed the chemical in the “Group 2A” category, meaning substances that are “probably carcinogenic to humans.” The agency found that NDMA is “carcinogenic in all animal species tested” and noted that the metabolism of NDMA by humans and animals is similar.

Is your law firm looking to refer Zantac cases? Please visit our Zantac Case Referral page for more information.

NDMA caused malignant tumor growth in several organs, in multiple species, via numerous routes of exposure (oral, inhalation, subcutaneous (under the skin), injections), with dose-response relationships appearing in several studies. Scientists are also gaining detailed knowledge of the body's biochemical mechanisms to repair NDMA DNA damage and how those mechanisms play a role in the progression towards cancer.

The FDA, Environmental Protection Agency (EPA), and World Health Organization (WHO) all classify as a substance capable of causing cancer.

Zantac Recall Update

The following companies issued voluntary Zantac recall announcements, citing safety concerns:

• American Health Packaging
• Amneal Pharmaceuticals
• Aurobindo Pharma USA
• Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and 150 mg, labeled by Walgreens, Walmart, and Rite-Aid)
• Appco Pharma
• Denton Pharma (dba Northwind Pharmaceuticals)
• Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
• GlaxoSmithKline (GSK)
• Glenmark Pharmaceuticals
• Golden State Medical Supply
• Lannett Company
• Novitium Pharma
• Perrigo Company
• Precision Dose
• Sandoz
• Sanofi

On April 1, 2020, the FDA issued a market withdrawal request of all Zantac (ranitidine) products, effective immediately. The FDA announcement noted that agency studies on Zantac showed “risk to public health.” As such, the agency said ranitidine products “will not be available for new or existing prescriptions or OTC use in the U.S.”

To stay updated on Zantac (ranitidine) recall announcements, we advise you to consult the FDA’s Recalls, Market Withdrawals, & Safety Alerts page. The FDA alerts consumers with the recall reason and lists Zantac recall lot numbers, if applicable.

Did the FDA Issue a Zantac Recall in 2019?

Despite evidence that Zantac can cause cancer, the U.S. Food and Drug Administration (FDA) did not immediately issue a Zantac recall in 2019. The agency warned consumers that testing of the popular heartburn medication Zantac (generic ranitidine) revealed a known cancer-causing chemical, N-nitrosodimethylamine (NDMA) at more than 3,000 times the legal daily intake limit.

While the FDA was reluctant to issue a Zantac recall in 2019, retail outlets like Walgreens, Walmart, Rite Aid, CVS and others pulled the popular medication from shelves. Generic drug makers like Sandoz (a division of Novartis), GSK, and Apotex also issued generic Zantac recalls in 2019; and nearly two dozen countries stopped or restricted sales of the popular medication.

The FDA issued a market withdrawal for Zantac in 2020. A market withdrawal is different than a recall. Per the FDA, here is the difference between a recall and a market withdrawal:

Market withdrawal: Involves a minor violation that would not be subject to legal action by the FDA.

Recall: The correction or removal of a marketed product that the FDA considers to be in violation of the laws it administers.

2018 NDMA Recall

In 2018, some companies issued recalls after the discovery of high levels of NDMA in multiple generic forms of the blood pressure drug valsartan. The levels of NDMA in these products, however, paled in comparison to that of Zantac.

The 2018 recalls were reportedly linked to NDMA that formed during manufacturing after active ingredient suppliers in India and China sold components of the medication to generic drug makers. Government officials have not commented on how NDMA ended up in the drugs.

Zantac Lawyers Call for FDA Ranitidine Recall

The Zantac cancer lawyers at Wisner Baum believe the FDA’s decision to issue a market withdrawal for Zantac is a necessary step toward protecting people from a dangerous drug. However, more can and should be done. Our firm has been calling for a Zantac recall since the summer of 2019 because there is no level of NDMA that is safe.

Zantac 360 with Famotidine on the Market Following Ranitidine Recall

In response to the Zantac recall announcements and the FDA’s market withdrawal for ranitidine, Sanofi announced a new Zantac product in 2021 called Zantac 360. Zantac 360 is made with famotidine as the active ingredient instead of ranitidine. With two different active ingredients, Zantac 360 is not the same as the original Zantac.

Many people may recognize famotidine, as it is the same active ingredient used in another popular OTC heartburn drug, Pepcid AC. While both famotidine and ranitidine are in the same class of drugs (H2 blockers), famotidine is considered a safe ranitidine replacement because it does not contain NDMA at high levels.

Does Zantac Cause Cancer?

Yes, Zantac can cause cancer. The ranitidine molecule produces high levels of N-Nitrosodimethylamine (NDMA) when the drug is used as directed. The U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the World Health Organization (WHO) classify NDMA as a cancer-causing chemical. The ranitidine molecule contains both a nitrite and a dimethylamine (DMA) group. These combine to form NDMA.

Numerous studies have found that the NDMA in Zantac causes bladder cancer, stomach cancer, pancreatic cancer, and other forms of cancer. Below we highlight some of the most important research on Zantac.

2019 Valisure Study: How Zantac (Ranitidine) Produces NDMA

In 2019, Valisure conducted batch testing for Zantac (ranitidine) using FDA-recommended protocols. Valisure found NDMA levels as high as 3,267,968 ng (nanograms) per Zantac tablet, more than 34,000 times higher than the FDA limit of 96 ng or .096 mcg (micrograms).

Wondering if the increased heat of the testing process may have contributed to these results, Valisure decided to test ranitidine under conditions that simulated those found in the stomach (simulated gastric fluid with sodium nitrite). NDMA levels, while not as high, were still extraordinary, ranging from 23,600 ng to 304,500 ng, over 3,100 times the FDA’s “safe” limit.

“Valisure’s testing reveals NDMA levels so high that the nitroso for NDMA likely comes from no other source than the ranitidine molecule itself.” [Nitroso refers to an atomic grouping of nitrogen and oxygen, such as found in the nitrite group of NDMA.]

— Valisure Citizen Petition on Ranitidine, September 9, 2019

Valisure also points to a third mechanism that could lead to NDMA production after Zantac is ingested – an enzyme, dimethylarginine dimethylaminohydrolase (DDAH), that can react with ranitidine to “liberate” DMA from ranitidine, making it available to combine with nitrite from the ranitidine molecule, nitrite circulating in the body, or “other potential pathways particularly in weak acidic conditions such as that in the kidney or bladder.” This mechanism, according to Valisure, could generate millions of nanograms of NDMA throughout the body.

2021 Valisure Study on Zantac (Ranitidine)

The 2021 Valisure Zantac study analyzed NDMA production “under simulated physiologic gastric states.” What does this mean exactly? Researchers conducted the study by mimicking the human stomach ingesting a Zantac tablet across a broad range of pH concentrations, ranitidine concentrations, and nitrite concentrations. The study used FDA-recommended protocols for determining nitrosamines in ranitidine tablets.

The study found that Zantac “may be a significant source of NDMA under a range of physiologically relevant conditions.” Under numerous conditions meant to simulate the human stomach, Zantac NDMA levels increased with increasing nitrite levels and decreasing pH levels up to three orders of magnitude beyond established limits. The authors cautioned, “these data support recent regulatory actions to limit ranitidine availability.”

Study on Zantac Published in Cancers

Cancers published a study on Zantac in December of 2020. Researchers looked at data from the FDA’s Adverse Events Reporting System (FAERS), searching adverse event reports of cancer stemming from primary and secondary use of proton pump inhibitors (PPIs) and H2 antagonists, the group of drugs to which Zantac belongs.

The study found elevated incidences of esophageal cancer, pharyngeal cancer, liver cancer, and pancreatic cancer, and stomach cancer, among others. The Cancers study provides “support for the assertion that NDMA contaminated ranitidine is associated with the occurrence of gastrointestinal cancer. This assertion was bolstered by an abundance of evidence demonstrating that NDMA exposure is associated with an increased risk of cancer in humans as well as animals.”

This research is similar to data from a 2000 study, which investigated the association between prescription ranitidine use and specific cancers. In the 2000 study, researchers found a statistically significant 2.4-fold increased risk for stomach cancer and esophageal cancer.

Sloan Kettering Study Finds Association Between Ranitidine and Cancer

Researchers from the Sloan Kettering Cancer Center conducted the study, ‘Ranitidine use, N-Nitrosodimethylamine (NDMA) production and variations in cancer diagnoses’. The study used similar methods to the 2021 Valisure study above.

The Sloan Kettering study analyzed ranitidine NDMA production under various simulated gastric conditions. Researchers also conducted an epidemiologic analysis to evaluate potential associations between ranitidine and several forms of cancer.

According to the authors, Zantac produces increasing amounts of NDMA over time (up to, and likely beyond four hours) and with increasing sodium nitrite concentrations. The study found positive associations for several cancers, including bladder cancer.

Epidemiological Studies of Zantac and Cancer

Very few epidemiological studies of patients taking Zantac have been conducted. In a study conducted by the National Cancer Institute, adult male health professionals with peptic ulcers were followed for 14 years (1986 – 2000). The subjects of the study were asked if they used either Tagamet or Zantac as a treatment. The authors of the study reported that use of either drug was associated with an increased risk of bladder cancer, though the increase fell short of statistical significance.

Other Zantac Studies

A true Zantac cancer study in humans—where humans are deliberately given Zantac to ingest to observe the results—has not been conducted and never will, as it would be unethical. However, a 1983 study of ranitidine in rodents found that it produced several “genotoxic effects,” including DNA fragmentation in the liver and gastric mucosa (the mucous membrane that lines the stomach). Significantly, studies of Tagamet (cimetidine), another antacid in Zantac’s class (H2 blockers), did not show DNA damage.

Genetic damage is known to be at the root of all cancers. A 2013 meta-analysis of studies that examined the relationship between various acid-suppressing drugs and gastric cancer concluded that that “acid suppressive drugs are associated with an increased risk of gastric cancer.”

These studies support three important points underlying the danger posed by Zantac:

• NDMA is carcinogenic in humans in exceedingly small amounts.
• Levels of NDMA produced by Zantac are extremely high.
• The problem with Zantac is not an “impurity” in the drug, but rather the design of the drug itself and how that design makes Zantac itself a carcinogen.

NDMA has not been directly tested in humans. The cancer risk is too high. However, we know from years of research that humans are regularly exposed to NDMA via many foods and beverages. This has provided a means of testing NDMA’s carcinogenic potential—and by extension the carcinogenicity of Zantac—in humans indirectly.